Abstract 3236: Comparison of Drug Eluting to Bare Metal Stents in North America: Findings from the NHLBI Dynamic Registry
Background: Although the effectiveness and safety of drug-eluting stents (DES) have been demonstrated in randomized controlled trials and European registries, outcomes for unselected pts in North America are limited. We sought to compare outcomes of unselected pts receiving a DES at a time when DES were commercially available in North America to a cohort of patients who received a bare metal stent (BMS) before DES were available.
Methods: The NHLBI Dynamic Registry is an ongoing prospective observational PCI study. Our analysis includes 3223 pts, 1460 that received at least one DES in 2004 and 1763 that received at least one bare metal stent (BMS) in 2001–2. Each cohort was followed for at least one-year.
Results: Differences in baseline characteristics were observed between the two groups with DES pts presenting with a higher prevalence of cardiovascular risk factors and prior PCI or CABG. Although more elective procedures were done in the DES group, more complex lesions were attempted. In-hospital mortality (DES 0.5% vs. BMS 1.1%, p=0.06), myocardial infarction (MI) (DES 2.2% vs BMS 1.9%, p=0.60) and composite major adverse cardiac events (MACE = death, MI, CABG) (DES 2.6% vs BMS 3.2%, p=0.29) were low and similar for both groups. At one year, mortality (DES 3.7% vs. BMS 4.3%, p=0.35) and MI (DES 4.5% vs BMS 4.7%, p=0.81) were comparable but rates of repeat revascularization by either repeat PCI or CABG were higher in the BMS group (DES 10.1%. BMS 15.0%, p<0.001) as was target vessel revascularization (DES 4.9% vs BMS 9.2%, p<0.001). Furthermore, the risk for one-year adverse events did not change after adjusting for important covariates (death HR 0.98, p=0.91; MI HR 0.98, p=0.92; repeat revascularization HR 0.57, p<0.001).
Conclusion: DES as used in routine clinical practice and in pts with more complex lesions was associated with similar high rates of procedural success and low rates of in-hospital adverse events compared to BMS. Moreover, at one-year, DES pts experienced less subsequent CABG and repeat PCI without any excess in adverse clinical events. These findings support the use of DES in routine clinical practice.